Quality Control and Regulatory Affairs Expertise

Quality Assurance

Quality Assurance Services coordinate all activities on a global basis to ensure trials conducted by Anovus Clinical Development on behalf of our clients always accurately follow strict regulatory guidelines and global quality standards. Our auditors are knowledgeable about local national and international regulations, standards and guidelines. Our auditors provide quality assurance services to our clients as a part of full services or a standalone project.

Services offered :

Clinical Investigator Site Audits
Clinical Database Audits or Study Report Review
Clinical Study Documents Review
Vendor Audits
System Audits

Regulatory Affairs

Anovus Clinical Research regulatory affairs professionals are dedicated to ensuring the successful and timely submission of your application.

Services offered :

Regulatory strategy for Global Drug Development
Consulting and preparation of all five CTD modules (M-1, M-2, M-3, M-4, M-5) for registration purpose in any country
Write, compile, and review regulatory submissions, including IND, NDA, BLA, PMA, ANDA, DMF, CTA, IMPD,    annual updates, risk management and evaluation plans
Variations, Amendments, Supplements , PSUR, PADER and 15 days alert reports to Applications
Clinical Trial Applications (IND/IMPD/CTA)
Drug Master Files and Site Master Files
Electronic Submission for Drug Establishment Registration and Drug Product Listing
Summary Product of Characteristics and Target Product Profile
Regulatory writing for submission (CMC)
Liaison with Regulatory Authorities
US Agent for non-US Pharmaceutical companies
Re-formatting old Dossier/DMF, NTA to CTD/eCTD format
Standardization of Documents to Support eCTD Format for submission

Site Management    Medical Writing    CDM   Statistical Analysis    Pharmacovigilance   CDISC   Regulatory Affairs

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